KAZIA ANNOUNCES UPCOMING DIPG DATA PRESENTATIONS TO ISPNO AND PUBLICATION IN EUROPEAN JOURNAL OF CANCER

SYDNEY, June 27, 2024 /PRNewswire/ — Kazia Therapeutics Limited (NASDAQ: KZIA), an oncology biotechnology company, is pleased to announce the presentation of new data from its lead program, paxalisib, at the 21st International Neurology Symposium -pediatric oncology (ISPNO 2024) June 29 – July 2, 2024In Philadelphia, Pennsylvania. Kazia simultaneously announces the publication of an article in the European Journal of Cancer highlighting the need to evaluate mutation-specific, CNS-penetrating inhibitors to treat pediatric patients with diffuse midline glioma (DMG).

There will be three paxalisib-related presentations in total at ISPNO, including data from the Phase 2 PNOC DMG-ACT (DMG-Adaptive Combination Trial, PNOC022) study evaluating the efficacy and safety of paxalisib in combination with ONC201. Building on data presented last year at the Society for NeuroOncology, 28^th At the annual meeting, principal investigators will discuss survival, pharmacokinetics, and tumor biomarkers of 132 patients with diffuse midline glioma (DMG) enrolled in the phase 2 study. Highlights from the abstract include a median overall survival of 13.2 months in cohort 1 (newly diagnosed, enrolled before radiation therapy n = 33), 15.8 months in cohort 2 (newly diagnosed, enrolled after radiation therapy n = 69), and 8.8 months in cohort 3 (relapsed patients, enrolled after progression n = 30).

The second presentation is based on new preclinical data using the addition of a novel HDAC inhibitor to the background treatment of paxalisib in DMG models. The third presentation will highlight the results of preclinical data of combination therapy of paxalisib and gemcitabine for patients with relapsed/relapsed atypical teratoid/rhabdoid tumors AT/RT by Johns Hopkins University researchers. Based on these results, the Pacific Pediatric Neuro-Oncology Consortium plans to include this combination therapy in its upcoming international AT/RT clinical trial.

Summary of abstracts (https://virtual.oxfordabstracts.com/#/event/5131/program?program&date=%222024-6-30%22)
Clinical tests; July 2, 2024; 8:15 a.m.
TRLS-14: PNOC022 Report: A Trial of Combination Therapy Using an Adaptive Platform Design for Patients With Diffuse Midline Glioma at Initial Diagnosis, Radiotherapy, or Progression
Cassie Kline, Andrea Franson, Anuradha BanerjeeAlyssa T. Reddy, et al.

Poster Session I; June 30, 2024; 5 p.m.
ATRT-15 Combining PI3K Inhibitor Paxalisib With Nucleoside Analog Gemcitabine to Improve Survival of Atypical Teratoid/Rhabdoid Tumors
Tyler FindlayKristen Malebranche, Anupa Geethadevi, Charles Eberhart, Jeffrey Rubens, Eric Raabe

DIPG-21 Preclinical evaluation of a multimodal therapeutic approach with Givinostat, Paxalisib and radiotherapy for diffuse midline glioma (DMG)
Aimée du Chatinier, Michaël H Meel, Piotr Waranecki, Dennis S Metselaar, Esther

The European Journal of Cancer publication Pediatric Strategy Forum for Medicinal Product Development of PI3-K, mTOR, AKT and GSK3β Inhibitors in Children and Adolescents with Cancer is the result of a two-day forum at April 2023 at the Dana Farber Cancer Institute. Comprised of patient advocates, regulators, researchers, and pediatric clinicians, the publication concludes: “Evaluation of mutation-specific, CNS-penetrating PI3-K inhibitors in children with GMD should be a priority and innovative regulatory approaches are needed given the sparse population. “. The article can be viewed at the following website: https://www.ejcancer.com/article/S0959-8049(24)00801-3/fulltext

About Kazia Therapeutics Limited
Kazia Therapeutics Limited (NASDAQ: KZIA) is an oncology-focused drug development company based in Sydney, Australia. Our lead program is paxalisib, an investigational brain-penetrating inhibitor of the PI3K/Akt/mTOR pathway, which is being developed to treat multiple forms of brain cancer. Approved by Genentech at the end of 2016, paxalisib is or has been the subject of around ten clinical trials in this disease. A completed Phase 2 study in glioblastoma reported early signs of clinical activity in 2021, and a pivotal glioblastoma study, GBM AGILE, has completed enrollment with final data expected shortly. Other clinical trials are underway in brain metastases, diffuse midline gliomas, and primary CNS lymphomas, with several reporting encouraging interim data. Paxalisib was granted rare pediatric disease designation and orphan drug designation by the FDA for diffuse intrinsic pontine glioma in August 2020 and for atypical teratoid/rhabdoid tumors in June 2022 and July 2022, respectively.

For more information, please visit www.kaziatherapeutics.com or follow us on Twitter @KaziaTx.

Forward-Looking Statements
This press release may contain forward-looking statements, which generally can be identified as such by the use of words such as “may”, “will”, “estimate”, “future”, “anticipate” or other similar words . Any statements describing Kazia’s future plans, strategies, intentions, expectations, objectives, goals or prospects, as well as other statements that are not historical facts, are also forward-looking statements, including, but not limited to , statements regarding: the timing of results and data related to Kazia’s clinical and preclinical trials and investigator-initiated trials of Kazia’s product candidates, and Kazia’s strategy and plans regarding its programs, including paxalisib and the EVT801. These statements are based on Kazia’s current expectations and projections regarding future events and future trends affecting its business and are subject to certain risks and uncertainties that could cause actual results to differ materially from those anticipated in the forward-looking statements, including risks and uncertainties: associated with clinical and preclinical trials and product development, related to regulatory approvals and related to the impact of global economic conditions. These and other risks and uncertainties are described in more detail in Kazia’s annual report, filed on Form 20-F with the U.S. Securities and Exchange Commission (SEC), and subsequent filings with the SEC. Kazia undertakes no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by applicable law. You should not place undue reliance on these forward-looking statements, which speak only as of the date of this announcement.

Publication of this announcement has been authorized by Dr. John Friend, CEO.

SOURCE Kazia Therapeutics Limited